NCT00004897

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa followed by surgery and/or radiation therapy in treating patients who have stage I, stage II, or stage III esophageal cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

7.8 years

First QC Date

March 7, 2000

Last Update Submit

June 8, 2012

Conditions

Esophageal Cancer

Keywords

stage I esophageal cancerstage II esophageal cancerstage III esophageal cancersquamous cell carcinoma of the esophagusadenocarcinoma of the esophagus

Interventions

recombinant interferon alfaBIOLOGICAL
cisplatinDRUG
fluorouracilDRUG
hydroxyureaDRUG
leucovorin calciumDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I-III squamous cell carcinoma or adenocarcinoma of the esophagus and gastro-esophageal junction Unidimensionally measurable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 270 days Hematopoietic: WBC greater than 3,000/mm3 Granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, alkaline phosphatase, and SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine less than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No serious cardiovascular disease that would preclude study Other: No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer No serious chronic medical illness that would preclude study No acute or chronic unresolved infection Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Interventions

Interferon-alphaCisplatinFluorouracilHydroxyureaLeucovorinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesTherapeutics

Study Officials

  • Claudia Tellez, MD

    Hematology-Oncology Associates of Illinois

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

July 26, 2004

Study Start

October 1, 1999

Primary Completion

July 1, 2007

Study Completion

November 1, 2007

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)